A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma

NCT02257567 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: GO293652014-001361-28
• Study Type: interventional
• Target: 331
• Locations: 13 countries
• Sites: 62

Brief Summary

This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with standard doses of bendamustine (B) and rituximab (R) or obinutuzumab (G) in participants with relapsed or refractory follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL). The study comprises two stages: a Phase Ib safety run-in stage and a Phase II stage. The anticipated time on treatment is 18 weeks for participants with DLBCL and 24 weeks for participants with FL.

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (11)

• Phase Ib: Percentage of Participants With Adverse Events (AEs)

  An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 4.0 (NCI-CTCAE, v4.0).

  From the study start up to the end of the study (up to approximately 84 months)

• Arm G+H (Phase II NF Cohort): Percentage of Participants With AEs

  An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. AEs were reported based on the NCI-CTCAE, v4.0. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.

  From Month 37 to Month 84 (up to approximately 47 months)

• Cohort 1a (Phase Ib): Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) to Polatuzumab Vedotin

  The number of participants with positive results for ADA against pola at Baseline and at any of the post-baseline assessment time-points were reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at baseline who has one or more post-baseline titer results that are at least 0.60 titer unit (t.u.) greater than the baseline titer result. Treatment emergent ADA is the sum of treatment-induced ADAs and treatment enhanced ADAs. Values have been rounded off to the nearest whole number.

  Baseline up to approximately Month 24

• Cohort 1b (Phase Ib): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin and Obinutuzumab

  The number of participants with positive results for ADA against pola and obinutuzumab at Baseline and at any of the post-baseline assessment time-points were reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at baseline who has one or more post-baseline titer results that are at least 0.60 t.u. greater than the baseline titer result. Treatment emergent ADA is the sum of treatment-induced ADAs and treatment enhanced ADAs. Values have been rounded off to the nearest whole number.

  Baseline up to approximately Month 24

• Arms G+H: (Phase II NF Cohorts): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin (Lyophilized)

  The number of participants with positive results for ADA against lyophilized pola at Baseline and at any of the post-baseline assessment time-points were reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at baseline who has one or more post-baseline titer results that are at least 0.60 t.u. greater than the baseline titer result. Treatment emergent ADA is the sum of treatment-induced ADAs and treatment enhanced ADAs. Values have been rounded off to the nearest whole number.

  From Month 37 to Month 84 (up to approximately 47 months)

• Phase II Randomized and NF Cohorts: Percentage of Participants With Complete Response (CR) at Primary Response Assessment (PRA) Based on Positron Emission Tomography (PET)-Computed Tomography (CT) Scan as Determined by Independent Review Committee (IRC)

  CR was assessed by IRC at PRA according to Modified Lugano Response Criteria (MLRC). Per MLRC, CR based on PET-CT was defined as complete metabolic response (MR) in lymph nodes and extralymphatic sites (ELS) with a score of 1, 2, or 3 with or without residual mass, on 5-point scale (5PS) where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \> mediastinum but ≤ liver; 4=uptake moderately \> liver; 5=uptake markedly higher than liver and/or new lesions no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, immunohistochemistry (IHC) negative. As pre-specified in the protocol data reported is combined for Arms G and H. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts) or after final dose of study treatment. Values have been rounded off to the nearest whole number.

  6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)

• Arm H (Phase II NF Cohort): Percentage of Participants With CR at PRA Based on PET-CT as Determined by the IRC

  CR was assessed by IRC at PRA according to MLRC. Per MLRC, CR based on PET-CT was defined as complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass, on 5PS where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \> mediastinum but ≤ liver; 4=uptake moderately \> liver; 5=uptake markedly higher than liver and/or new lesions no evidence of FDG-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, IHC negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts) or after final dose of study treatment. Values have been rounded off to the nearest whole number.

  6-8 weeks after Cycle 6, Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks)

• Arm G (Phase II NF Cohort): Area Under Concentration-Time Curve (AUC) of Polatuzumab Vedotin (Lyophilized)

  Pharmacokinetic (PK) of three pola-related analytes: antibody conjugated monomethyl auristatin E (acMMAE), total antibody, and unconjugated MMAE were measured. The unit of measure for AUC is nanograms\*day per milliliters.

  Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, (each cycle is 21 days DLBCL cohorts) up to approximately 9 weeks

• Arm G (Phase II NF Cohort): Maximum Concentration (Cmax) of Polatuzumab Vedotin (Lyophilized)

  PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

  Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4,(cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks

• Arm G (Phase II NF Cohort): Systemic Clearance (CL) of Polatuzumab Vedotin (Lyophilized)

  PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured. Unit of measure for CL is milliliters per day per kilograms (mL/day/kg)

  Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, (cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks

• Arm G (Phase II NF Cohort): Steady-State Volume of Distribution (Vss) of Polatuzumab Vedotin (Lyophilized)

  PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

  Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, Day (cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks

Secondary Outcomes (67)

• Phase II: Percentage of Participants With AEs

  From the study start up to the end of the study (up to approximately 84 months)

• Arms A and C (Phase II): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin

  Baseline to approximately Month 24

• Arms E and F (Phase II): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin and Obinutuzumab

  Baseline to approximately Month 24

• Phase II: Percentage of Participants With CR at PRA Based on PET-CT as Determined by the Investigator

  6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)

• Phase II Expansion Cohorts and Arm G (Phase II NF Cohort): Percentage of Participants With CR at PRA Based on PET-CT as Determined by the IRC

  6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)

Study Arms (12)

Arm A (Phase II Randomization): Polatuzumab+BR in FL

EXPERIMENTAL

Polatuzumab vedotin will be administered with bendamustine and rituximab in participants with FL.

Drug: Bendamustine; Drug: Polatuzumab vedotin (Liquid); Drug: Rituximab

Arm B (Phase II Randomization): BR in FL

ACTIVE COMPARATOR

Bendamustine and rituximab will be administered alone (that is, without polatuzumab vedotin) as a control arm in participants with FL.

Drug: Bendamustine; Drug: Rituximab

Arm C (Phase II Randomization): Polatuzumab+BR in DLBCL

EXPERIMENTAL

Polatuzumab vedotin will be administered with bendamustine and rituximab in participants with DLBCL.

Drug: Bendamustine; Drug: Polatuzumab vedotin (Liquid); Drug: Rituximab

Arm D (Phase II Randomization): BR in DLBCL

ACTIVE COMPARATOR

Bendamustine and rituximab will be administered alone (that is, without polatuzumab vedotin) as a control arm in participants with DLBCL.

Drug: Bendamustine; Drug: Rituximab

Arm E (Phase II Expansion): Polatuzumab+BG in FL

EXPERIMENTAL

Polatuzumab vedotin will be administered with bendamustine and obinutuzumab in participants with FL.

Drug: Bendamustine; Drug: Obinutuzumab; Drug: Polatuzumab vedotin (Liquid)

Arm F (Phase II Expansion): Polatuzumab+BG in DLBCL

EXPERIMENTAL

Polatuzumab vedotin will be administered with bendamustine and obinutuzumab in participants with DLBCL.

Drug: Bendamustine; Drug: Obinutuzumab; Drug: Polatuzumab vedotin (Liquid)

Cohort 1A (Phase Ib Safety Run-In): Polatuzumab+BR in DLBCL

EXPERIMENTAL

Polatuzumab vedotin will be administered with bendamustine and rituximab in participants with DLBCL.

Drug: Bendamustine; Drug: Polatuzumab vedotin (Liquid); Drug: Rituximab

Cohort 1A (Phase Ib Safety Run-In): Polatuzumab+BR in FL

EXPERIMENTAL

Polatuzumab vedotin will be administered with bendamustine and rituximab in participants with FL.

Drug: Bendamustine; Drug: Polatuzumab vedotin (Liquid); Drug: Rituximab

Cohort 1B (Phase Ib Safety Run-In): Polatuzumab+BG in DLBCL

EXPERIMENTAL

Polatuzumab vedotin will be administered with bendamustine and obinutuzumab in participants with DLBCL.

Drug: Bendamustine; Drug: Obinutuzumab; Drug: Polatuzumab vedotin (Liquid)

Cohort 1B (Phase Ib Safety Run-In): Polatuzumab+BG in FL

EXPERIMENTAL

Polatuzumab vedotin will be administered with bendamustine and obinutuzumab in participants with FL.

Drug: Bendamustine; Drug: Obinutuzumab; Drug: Polatuzumab vedotin (Liquid)

Arm G (Phase II NF Cohort): Polatuzumab+BR in DLBCL

EXPERIMENTAL

In this New Formulation (NF) cohort, Polatuzumab vedotin (lyophilized) will be administered with bendamustine and rituximab in participants with DLBCL.

Drug: Bendamustine; Drug: Rituximab; Drug: Polatuzumab vedotin (Lyophilized)

Arm H (Phase II NF Cohort): Polatuzumab+BR in DLBCL

EXPERIMENTAL

In this NF cohort, Polatuzumab vedotin (lyophilized) will be administered with bendamustine and rituximab in participants with DLBCL.

Drug: Bendamustine; Drug: Rituximab; Drug: Polatuzumab vedotin (Lyophilized)

Interventions

Bendamustine DRUG

Bendamustine 90 milligrams per meter-squared (mg/m\^2) per day administered IV on Days 2 and 3 of Cycle 1, then on Days 1 and 2 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).

Also known as: Treanda; Ribomustin; Levact

Arm A (Phase II Randomization): Polatuzumab+BR in FL; Arm B (Phase II Randomization): BR in FL; Arm C (Phase II Randomization): Polatuzumab+BR in DLBCL; Arm D (Phase II Randomization): BR in DLBCL; Arm E (Phase II Expansion): Polatuzumab+BG in FL; Arm F (Phase II Expansion): Polatuzumab+BG in DLBCL; Arm G (Phase II NF Cohort): Polatuzumab+BR in DLBCL; Arm H (Phase II NF Cohort): Polatuzumab+BR in DLBCL; Cohort 1A (Phase Ib Safety Run-In): Polatuzumab+BR in DLBCL; Cohort 1A (Phase Ib Safety Run-In): Polatuzumab+BR in FL; Cohort 1B (Phase Ib Safety Run-In): Polatuzumab+BG in DLBCL; Cohort 1B (Phase Ib Safety Run-In): Polatuzumab+BG in FL

Obinutuzumab DRUG

Obinutuzumab 1000 milligrams (mg) IV on Days 1, 8, and 15 of Cycle 1 and on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).

Also known as: GA101; Gazyva; Gazyvaro

Arm E (Phase II Expansion): Polatuzumab+BG in FL; Arm F (Phase II Expansion): Polatuzumab+BG in DLBCL; Cohort 1B (Phase Ib Safety Run-In): Polatuzumab+BG in DLBCL; Cohort 1B (Phase Ib Safety Run-In): Polatuzumab+BG in FL

Polatuzumab vedotin (Liquid) DRUG

Polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) administered IV on Day 2 of Cycle 1, then on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).

Also known as: DCDS4501A

Arm A (Phase II Randomization): Polatuzumab+BR in FL; Arm C (Phase II Randomization): Polatuzumab+BR in DLBCL; Arm E (Phase II Expansion): Polatuzumab+BG in FL; Arm F (Phase II Expansion): Polatuzumab+BG in DLBCL; Cohort 1A (Phase Ib Safety Run-In): Polatuzumab+BR in DLBCL; Cohort 1A (Phase Ib Safety Run-In): Polatuzumab+BR in FL; Cohort 1B (Phase Ib Safety Run-In): Polatuzumab+BG in DLBCL; Cohort 1B (Phase Ib Safety Run-In): Polatuzumab+BG in FL

Rituximab DRUG

Rituximab standard dose, 375 mg/m\^2 IV on Day 1 of each cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).

Also known as: Rituxan; MabThera

Arm A (Phase II Randomization): Polatuzumab+BR in FL; Arm B (Phase II Randomization): BR in FL; Arm C (Phase II Randomization): Polatuzumab+BR in DLBCL; Arm D (Phase II Randomization): BR in DLBCL; Arm G (Phase II NF Cohort): Polatuzumab+BR in DLBCL; Arm H (Phase II NF Cohort): Polatuzumab+BR in DLBCL; Cohort 1A (Phase Ib Safety Run-In): Polatuzumab+BR in DLBCL; Cohort 1A (Phase Ib Safety Run-In): Polatuzumab+BR in FL

Polatuzumab vedotin (Lyophilized) DRUG

Participants in the New Formulation (NF) Cohort (Arms G and H) will follow the same schedule and dosing requirements as participants in the other Phase II cohorts (Arms A-F).

Also known as: DCDS4501S

Arm G (Phase II NF Cohort): Polatuzumab+BR in DLBCL; Arm H (Phase II NF Cohort): Polatuzumab+BR in DLBCL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed relapsed or refractory FL (Grades 1, 2, or 3a) or relapsed or refractory DLBCL
• If the participant has received prior bendamustine, response duration must have been greater than (\>) 1 year (for participants who have relapse disease after a prior regimen)
• At least one bi-dimensionally measurable lesion on imaging scan defined as \>1.5 centimeters (cm) in its longest dimension
• Confirmed availability of archival or freshly collected tumor tissue
• The Phase II NF Cohorts (Arms G and H) will be required to submit tissue and pathology report for central pathology review.
• Life expectancy of at least 24 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Adequate hematological function unless inadequate function is due to underlying disease

You may not qualify if:

• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (MAbs, or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
• Contraindication to bendamustine, rituximab, or obinutuzumab
• Prior use of any MAb, radioimmunoconjugate, or antibody-drug conjugate (ADC) within 4 weeks or 5 half-lives before Cycle 1 Day 1
• Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to Cycle 1 Day 1
• Ongoing corticosteroid use \>30 mg per day prednisone or equivalent, for purposes other than lymphoma symptom control
• Completion of autologous stem cell transplant (SCT) within 100 days prior to Cycle 1 Day 1
• Prior allogeneic SCT
• Eligibility for autologous SCT
• Grade 3b FL
• History of transformation of indolent disease to DLBCL
• Primary or secondary CNS lymphoma
• Current Grade \>1 peripheral neuropathy
• Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or significant pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)
• Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to Cycle 1 Day 1
• Suspected or latent tuberculosis

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (62)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3300, United States

Location

Clearview Cancer Institute

Huntsville, Alabama, 35805, United States

Location

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

Univ of Colorado Canc Ctr

Aurora, Colorado, 80045, United States

Location

Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)

Jacksonville, Florida, 32256, United States

Location

Emory Univ Winship Cancer Inst

Atlanta, Georgia, 30322, United States

Location

Joliet Oncology-Hematology; Associates, Ltd.

Joliet, Illinois, 60435, United States

Location

Horizon Oncology Research, Inc.

Lafayette, Indiana, 47905, United States

Location

Weinberg CA Inst Franklin Sq

Baltimore, Maryland, 21237, United States

Location

Regional Cancer Care Associates LLC - Morristown

Morristown, New Jersey, 07962, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87131, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

West Clinic

Germantown, Tennessee, 38138, United States

Location

Swedish Cancer Inst.

Seattle, Washington, 98104, United States

Location

Northwest Medical Specialties

Tacoma, Washington, 98405, United States

Location

Prince of Wales Hospital; Oncology

Randwick, New South Wales, 2031, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Adelaide Cancer Centre

Kurralta Park, South Australia, 5037, Australia

Location

Monash Medical Centre; Haematology Research

Clayton, Victoria, 3168, Australia

Location

BCCA-Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Queen Elizabeth II Health Sciences Centre; Oncology

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Hopital Maisonneuve- Rosemont; Oncology

Montreal, Quebec, H1T 2M4, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

Brno, 625 00, Czechia

Location

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05, Czechia

Location

Fakultní nemocnice Ostrava Klinika hematoonkologie

Ostrava, 70852, Czechia

Location

I Interni klinika; Vseobecna fakultni nemocnice

Prague, 128 08, Czechia

Location

Chu Site Du Bocage;Hematologie Clinique

Dijon, 21079, France

Location

Centre Hospitalier Departemental Les Oudairies

La Roche-sur-Yon, 85925, France

Location

Centre Leon Berard; Departement Oncologie Medicale

Lyon, 69373, France

Location

CHU Saint Eloi; Service d'Hématologie Clinique

Montpellier, 34295, France

Location

CHU Lyon Sud - Service Hématologie

Pierre-Bénite, 69310, France

Location

Centre Henri Becquerel; Hematologie

Rouen, 76038, France

Location

HELIOS Klinikum Erfurt - Innere Medizin - 4. Medizinische Klinik, Hämatologie

Erfurt, 99089, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Abt. für Hämatologie und Onkologie

Mainz, 55131, Germany

Location

Joh. Wesling Klinikum Minden; Klinik fuer Hämatologie und Onkologie

Minden, 32429, Germany

Location

Gemeinschaftspraxis für Hämatologie und Onkologie

Münster, 48153, Germany

Location

Klinik der Uni Regensburg; Hämatologie/Onkologie, Studienzentrale

Regensburg, 93053, Germany

Location

Semmelweis University, First Dept of Medicine

Budapest, 1083, Hungary

Location

National Institute of Oncology, A Dept of Internal Medicine

Budapest, 1122, Hungary

Location

University of Debrecen Medical and Health Science Center, Institute of Internal medicine Building B

Debrecen, 4032, Hungary

Location

Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica

Napoli, Campania, 80131, Italy

Location

A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia

Brescia, Lombardy, 25123, Italy

Location

Irccs Istituto Europeo Di Oncologia (IEO); Emato-Oncologia

Milan, Lombardy, 20141, Italy

Location

Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia

Alessandria, Piedmont, 15121, Italy

Location

UMC St. Radboud; Hematology

Nijmegen, 6525 GA, Netherlands

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Hospital Universitari Vall d'Hebron; Servicio de Hematologia

Barcelona, 08035, Spain

Location

Hospital Clinic i Provincial de Barcelona; Hematology

Barcelona, 08036, Spain

Location

Hospital Universitario la Paz; Servicio de Hematologia

Madrid, 28046, Spain

Location

Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

Salamanca, 37007, Spain

Location

Hospital Universitario Virgen del Rocio; Servicio de Hematologia

Seville, 41013, Spain

Location

Ankara University; Hematology

Ankara, 06620, Turkey (Türkiye)

Location

Dokuz Eylul Uni ; Hematology

Izmir, 35100, Turkey (Türkiye)

Location

Ondokuzmayis University Medical Faculty Heamatology Department

Samsun, 55139, Turkey (Türkiye)

Location

Karadeniz Technical Uni School of Medicine; Hematology

Trabzon, 61800, Turkey (Türkiye)

Location

KINGS COLLEGE HOSPITAL; Commercial R&D Amendments, Kings Health Partners Clinical Trials Office

London, SE1 9RT, United Kingdom

Location

Christie Hospital Nhs Trust; Medical Oncology

Manchester, M2O 4BX, United Kingdom

Location

Nottingham City Hospital; Dept of Haematology

Nottingham, NG5 1PB, United Kingdom

Location

Southampton General Hospital; Somers Cancer Research Building

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (8)

• Jemaa S, Ounadjela S, Wang X, El-Galaly TC, Kostakoglu L, Knapp A, Ku G, Musick L, Sahin D, Wei MC, Yin S, Bengtsson T, De Crespigny A, Carano RAD. Automated Lugano Metabolic Response Assessment in 18F-Fluorodeoxyglucose-Avid Non-Hodgkin Lymphoma With Deep Learning on 18F-Fluorodeoxyglucose-Positron Emission Tomography. J Clin Oncol. 2024 Sep 1;42(25):2966-2977. doi: 10.1200/JCO.23.01978. Epub 2024 Jun 6.

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• Bosch F, Kuruvilla J, Vassilakopoulos TP, Maio DD, Wei MC, Zumofen MB, Nastoupil LJ. Indirect Treatment Comparisons of Mosunetuzumab With Third- and Later-Line Treatments for Relapsed/Refractory Follicular Lymphoma. Clin Lymphoma Myeloma Leuk. 2024 Feb;24(2):105-121. doi: 10.1016/j.clml.2023.09.007. Epub 2023 Sep 28.

  PMID: 37981564 DERIVED

• Herrera AF, Tracy S, Croft B, Opat S, Ray J, Lovejoy AF, Musick L, Paulson JN, Sehn LH, Jiang Y. Risk profiling of patients with relapsed/refractory diffuse large B-cell lymphoma by measuring circulating tumor DNA. Blood Adv. 2022 Mar 22;6(6):1651-1660. doi: 10.1182/bloodadvances.2021006415.

  PMID: 35086141 DERIVED

• Sehn LH, Hertzberg M, Opat S, Herrera AF, Assouline S, Flowers CR, Kim TM, McMillan A, Ozcan M, Safar V, Salles G, Ku G, Hirata J, Chang YM, Musick L, Matasar MJ. Polatuzumab vedotin plus bendamustine and rituximab in relapsed/refractory DLBCL: survival update and new extension cohort data. Blood Adv. 2022 Jan 25;6(2):533-543. doi: 10.1182/bloodadvances.2021005794.

  PMID: 34749395 DERIVED

• Betts KA, Thuresson PO, Felizzi F, Du EX, Dieye I, Li J, Schulz M, Masaquel AS. US cost-effectiveness of polatuzumab vedotin, bendamustine and rituximab in diffuse large B-cell lymphoma. J Comp Eff Res. 2020 Oct;9(14):1003-1015. doi: 10.2217/cer-2020-0057. Epub 2020 Oct 8.

  PMID: 33028076 DERIVED

• Shi R, Lu T, Ku G, Ding H, Saito T, Gibiansky L, Agarwal P, Li X, Jin JY, Girish S, Miles D, Li C, Lu D. Asian race and origin have no clinically meaningful effects on polatuzumab vedotin pharmacokinetics in patients with relapsed/refractory B-cell non-Hodgkin lymphoma. Cancer Chemother Pharmacol. 2020 Sep;86(3):347-359. doi: 10.1007/s00280-020-04119-8. Epub 2020 Aug 8.

  PMID: 32770353 DERIVED

• Lu T, Gibiansky L, Li X, Li C, Shi R, Agarwal P, Hirata J, Miles D, Chanu P, Girish S, Jin JY, Lu D. Exposure-safety and exposure-efficacy analyses of polatuzumab vedotin in patients with relapsed or refractory diffuse large B-cell lymphoma. Leuk Lymphoma. 2020 Dec;61(12):2905-2914. doi: 10.1080/10428194.2020.1795154. Epub 2020 Jul 24.

  PMID: 32705923 DERIVED

• Sehn LH, Herrera AF, Flowers CR, Kamdar MK, McMillan A, Hertzberg M, Assouline S, Kim TM, Kim WS, Ozcan M, Hirata J, Penuel E, Paulson JN, Cheng J, Ku G, Matasar MJ. Polatuzumab Vedotin in Relapsed or Refractory Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2020 Jan 10;38(2):155-165. doi: 10.1200/JCO.19.00172. Epub 2019 Nov 6.

  PMID: 31693429 DERIVED

MeSH Terms

Conditions

Lymphoma

Interventions

Bendamustine Hydrochloride; obinutuzumab; polatuzumab vedotin; Fluid Therapy; Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Therapy; Therapeutics; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 6, 2014
• Study Start: October 15, 2014
• Primary Completion: October 21, 2021
• Study Completion: October 21, 2021
• Last Updated: November 14, 2022
• Results First Posted: November 14, 2022

Record last verified: 2022-10

Locations

NL (1); AU (4); GB (4); ES (5); TU (4); IT (4); FR (6); CZ (4); KR (2); CA (4); US (16); DE (5); HU (3)